Reported Nov 6, 2019 · Terminated
Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2)…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
- Convex Two-Piece Ostomy System (Skin Barrier)
- marketed under the following brands1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3)
- Natura 4) Varicare Product Usagestoma management
- Lot codes and dates
- 1) Combihesive Natura Durahesive Product Code Lot Number2) SurFit Natura Durahesive Product Code Lot Number
450 of 450 codes
4045927M006304045928A068084045928C047614045937G028524045937L001384045938B052574045938E013044045938E023354045947G056974045947H049214045948A007424045948D005954045948E030284045948G039321252787L030701252787L030721252797K051871252798F006701252797E023121252797K051851252807D011731252808A007321252808E046401252807D011711252807D047171252808A007351252817C053981252817K005191252817K059081252818E01678
3) Natura Product Code Lot Number462 of 462 codes
4022007J012954022017F038784022018A060154022027H014794022027K053664022028G040124022037K034224022037L010604022038C009604022047F009554022047H014754022047K021534022048G016124022048H045214022057F061394022057G036444022058D004744022058G040154022067G036484022067L013384022077K020474022078A007384022087H049304022087J042334022097H034974022107H049184022117H057364022007J012944022017F038774022017H04125
4) Varicare Product Code Lot Number338 of 338 codes
4045927K007464045927M030424045928A043444045928E032314045947F000034045947G005784045947L010354045947M034324045948B032754045948D050744045948G032964045948J009724131777L030684131787E022704131788A007264131807K005214131807K059074131808F006984131817E017104131817G001664131817M039814131818G009274131818H043564131827F031554131827L010444131828B038604131828F010474131847J049704131848G034994131857H06314
1252787J000061252797F040031252797J000081252798F006831252807M039721252808A007331252808E046391252817E018361252817K005241252827J000011252828E038431252837F031541252837M035801252838F010491252847H021901252857J049691252858G03496
- 1) Combihesive Natura Durahesive Product Code Lot Number
- Amount recalled
- 8,008131 skin barriers
Why it was recalled
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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